Impact of Hyperbilirubinemia Among HIV Patients Treated With Atazanavir

NCT ID: NCT02532673

Last Updated: 2015-08-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-08-31

Study Completion Date

2015-05-31

Brief Summary

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The purpose of this study is to determine whether HIV patients on Atazanavir who have Hyperbilirubinemia have different outcomes from those without Hyperbilirubinemia.

Detailed Description

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Conditions

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HIV/AIDS

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Hyperbilirubinemia Cohort

Patients will be included who have evidence of hyperbilirubinemia (laboratory test of grade 2 or greater or \> 2 medical claims with an International Classification of Diseases, Ninth Revision, Clinical Modification code of 782.4 or 277.4 in any position) in the first 90 days after initiating Atazanavir therapy.

No interventions assigned to this group

Non-hyperbilirubinemia cohort

Patients will be included who have no evidence of hyperbilirubinemia (no laboratory test of grade 2 or greater or any medical claims with an International Classification of Diseases, Ninth Revision, Clinical Modification of 782.4 or 277.4 in any position) in the 12-month follow-up period.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of Human immunodeficiency virus
* Treatment with Atazanavir
* 18 yrs and older
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Related Links

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Other Identifiers

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AI424-531

Identifier Type: -

Identifier Source: org_study_id

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